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Wound Closure Device

Left chest with Brijjit® FMTB for Mastectomy

N/A
Waitlist Available
Led By Rachel Bluebond-Langner
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months post-surgery visit
Awards & highlights

Study Summary

This study will evaluate the use of Brijjit® for wound closure in individuals undergoing bilateral double incision gender affirming mastectomies with a single surgeon (Rachel Bluebond-Langner, MD). The study will be a randomized prospective interventional study utilizing internal controls (one side of chest receives intervention, other serves as control). Primary endpoints will include scar appearance/quality and wound complications

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months post-surgery visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months post-surgery visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Colorimetry of Scar
Cicatrization
Subjective scar evaluation by patient outcomes using POSAS
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Right chest with Brijjit® FMTBExperimental Treatment1 Intervention
Patients will be assigned to have their right chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.
Group II: Left chest with Brijjit® FMTBExperimental Treatment1 Intervention
Patients will be assigned to have their left chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,370 Previous Clinical Trials
840,804 Total Patients Enrolled
Rachel Bluebond-LangnerPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Brijjit® for Wound Closure in Gender Affirming Mastectomies
2022. "Brijjit® for Wound Closure in Gender Affirming Mastectomies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368519.
~0 spots leftby May 2025
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